Gurtner GC, Garcia AD, Bakewell K, Alarcon JB, et al.
International wound journal. Date of publication 2020 Feb 1;volume 17(1):55-64.
1. Int Wound J. 2020 Feb;17(1):55-64. doi: 10.1111/iwj.13231. Epub 2019 Nov 15.
A retrospective matched-cohort study of 3994 lower extremity wounds of multiple
etiologies across 644 institutions comparing a bioactive human skin allograft,
TheraSkin, plus standard of care, to standard of care alone.
Gurtner GC(1), Garcia AD(2), Bakewell K(3), Alarcon JB(4).
Author information:
(1)Department of Surgery - Plastic and Reconstructive Surgery, Stanford
University, Palo Alto, California.
(2)Geriatric Medicine, Baylor College of Medicine, Houston, Texas.
(3)NLP Logix, Jacksonville, Florida.
(4)Apex Research Services LLC, Apex, North Carolina.
Most chronic wounds are related to comorbidities, for which no clinical trials
are performed. This retrospective propensity matched-cohort study examined data
from 2 074 000 lower extremity wounds across 644 institutions to determine the
effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC
alone (n = 1997). Multivariate modelling comparing outcomes such as healing
rates, percent area reductions (PARs), amputations, recidivism, treatment
completion, and medical transfers were evaluated. A higher proportion of wounds
in the treatment group compared with the controls were more likely to close
(68.3% versus 60.3%), particularly wounds with exposed structures (64% versus
50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control
group was 2.75x more likely to require amputation than the treatment group. The
combination of propensity matching and logistic regression analysis on a
particularly large database demonstrated that wounds treated with TheraSkin had
higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower
recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical
transfers (16.1% versus 23.5%) than SOC alone. This study considered data from
complex wounds typically excluded from controlled trials and supports the idea
that real-world evidence studies can be valid and reliable.
© 2019 The Authors. International Wound Journal published by
Medicalhelplines.com Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.13231
PMCID: PMC7004012
PMID: 31729833 [Indexed for MEDLINE]
Conflict of interest statement: None noted.
